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Clinical Study of Generic and Brand Bupropion in Depression (BALANCE)

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ClinicalTrials.gov Identifier: NCT02209597
Recruitment Status : Active, not recruiting
First Posted : August 6, 2014
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Determine bioequivalence between branded and generic bupropion extended release (XL) products (and between generic products) at steady state in patients with major depressive disorder.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Wellbutrin XL® 300mg Drug: 300mg bupropion XL 1 Drug: 300mg bupropion XL 2 Drug: 300mg bupropion XL 3 Not Applicable

Detailed Description:
The protocol is a prospective, randomized, double-blinded, crossover study in 75 subjects (target, 60 evaluable) with Major Depressive Disorder (MDD) receiving bupropion HCl 300mg XL (branded or generic). Subjects will be studied for a total of approximately 28 weeks: an approximately 4 week lead-in phase during which participants remain on their existing bupropion product, and then four randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics). For each of the four bupropion products, subjects will have (a) formal pharmacokinetic evaluation (24 hr plasma and urine) at steady-state, (b) every 3-week in-person standard structured clinical evaluations of depressive symptoms and side effects, and (c) once daily smart phone-based assessments to capture information on symptoms and side effects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Bioequivalence and Clinical Effects of Generic and Brand Bupropion
Actual Study Start Date : June 2014
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wellbutrin XL® 300mg
Subjects will take each 300mg Wellbutrin XL product for 6 weeks, and then be switched to another product without washout, according to their randomization schedule. During the 2nd-3rd week on each product, subjects will visit the study clinic for a bupropion pharmacokinetic session, an objective assessment of depression and side effects
Drug: Wellbutrin XL® 300mg
Other Name: generic bupropion XL 300mg

Experimental: 300mg bupropion XL 1
Subjects will take each 300mg bupropion XL product for 6 weeks, and then be switched to another product without washout, according to their randomization schedule. During the 2nd-3rd week on each product, subjects will visit the study clinic for a bupropion pharmacokinetic session, an objective assessment of depression and side effects
Drug: 300mg bupropion XL 1
Experimental: 300mg bupropion XL 2
Subjects will take each 300mg bupropion XL product for 6 weeks, and then be switched to another product without washout, according to their randomization schedule. During the 2nd-3rd week on each product, subjects will visit the study clinic for a bupropion pharmacokinetic session, an objective assessment of depression and side effects
Drug: 300mg bupropion XL 2
Experimental: 300mg bupropion XL 3
Subjects will take each 300mg bupropion XL product for 6 weeks, and then be switched to another product without washout, according to their randomization schedule. During the 2nd-3rd week on each product, subjects will visit the study clinic for a bupropion pharmacokinetic session, an objective assessment of depression and side effects.
Drug: 300mg bupropion XL 3



Primary Outcome Measures :
  1. Cmax for racemic bupropion, hydroxybupropion, erythrohydrobupropion and threohydrobupropion [ Time Frame: For 24 hours approximately every 6 weeks ]
  2. AUC0-24 for racemic bupropion, hydroxybupropion, erythrohydrobupropion and threohydrobupropion [ Time Frame: 24 hours at each PK timepoint ]

Secondary Outcome Measures :
  1. Relapse of MDD [ Time Frame: 28 weeks ]
  2. Change in symptoms of depression [ Time Frame: 28 weeks ]
  3. Change in side effects of medication [ Time Frame: 28 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Each subject must meet all of the following criteria:

  1. Adult outpatients age 18-75 years
  2. Currently on once daily bupropion HCl 300mg XL (brand or any generic), for a minimum of 4 months
  3. Major depressive disorder (MDD), in partial or full remission for at least 4 months, as confirmed by the SCID. Spontaneous relapse of depression unrelated to medication changes is less likely - about 5% chance per year - after remission has been maintained for at least 4 months.2
  4. Ability to understand and willingness to comply with study procedures, and to provide written informed consent

Exclusion Criteria

Subjects will not be enrolled if any of the following criteria exist:

  1. Remission from depression not clearly attributed to bupropion treatment
  2. Current severe side effects attributable to bupropion
  3. Poor adherence to bupropion treatment per patient self- report and history of refill persistence
  4. History of active seizure disorder, or seizure treatment within past year
  5. History of significant hepatic or renal disease, based on physician assessment
  6. Currently taking drugs or natural products known to influence cytochrome P450B6 (CYP2B6) activity
  7. Currently taking drugs for hepatitis C or multiple sclerosis, due to their ability to cause depression
  8. Dementia or other significant cognitive impairment, per diagnosis or investigative team's assessment
  9. Lifetime diagnosis of schizophrenia, schizoaffective or schizophreniform dis-order, delusional disorder, or current psychotic symptoms diagnosed by SCID
  10. Abuse of or dependence on alcohol or other substances within the past 6 months as determined by SCID, and confirmed by study physician interview
  11. Current suicidal ideation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209597


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Evan D Kharasch, MD, PhD Washington Univesity School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02209597     History of Changes
Other Study ID Numbers: 201312021
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

Keywords provided by Washington University School of Medicine:
Major Depressive Disorder
MDD
bupropion XL
Wellbutrin XL

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors